Electrical stimulation for treatment of incontinence and other neuro-muscular disorders

ABSTRACT

Electrical stimulation for the treatment of neuro-muscular disorders, in particular incontinence. A portable electrical stimulation apparatus for treatment of incontinence, comprising one or more electrodes (302) for applying one or more electrical stimulation signals to a patient&#39;s body, a signal generator for generating the electrical stimulation signal(s), one or more conductive leads for connecting the signal generator to the electrode(s), to deliver the electrical stimulation signal to the electrode(s); and a power supply, characterized in that the apparatus includes an instruction storage or a programming device for imparting a set of instructions to the signal generator, the signal generator being responsive to the instruction storage or programming device so that the generated signal adopts signal waveform characteristics selected in accordance with said set of instructions.

This application is a division of application Ser. No. 08/335,750, filedNov. 8, 1994 now U.S. Pat. No. 5,562,7\.

TECHNICAL FIELD

The present invention relates to electrical nerve and muscle stimulationand particularly although not exclusively to electro-medical treatmentfor urinary and faecal incontinence, primarily in women but equallyadaptable for men.

BACKGROUND ART

Conventional electro-stimulation treatments for urinary and faecalincontinence require a patient to apply stimulation via an internalelectrode in electrical contact with the body. Treatment is applied forperiods ranging from 10 minutes to several hours each day.

A conventional electro-stimulation system includes pulse generatorhoused in a portable battery box, and an electrode pad for attachment tothe patient. Such systems are often used for the relief of chronic backpain or induced muscle contraction. These systems fall under the generalclassification of transcutaneous electrical nerve stimulation systems(TENS).

The above mentioned electro-stimulation systems conventionally use adrive signal to the electrode which is characterised by a sine wave,square wave, or spike impulse geometry, and is either monophasic,capacitively coupled monophasic, biphasic or asymmetric. Differingtherapeutic effects are achieved using different drive signal types.Conventionally such stimulation systems allow for a variation of drivesignal pulse width or frequency by the patient. However each such knownportable stimulation system has electronics which are dedicated forproviding a specific predetermined drive signal having a geometry andother characteristics matched to the intended therapeutic effect.Adjustment of the control signal is conventionally provided byelectronic push switches and or rotational control knobs. Such switchesand knobs can often be tampered with by the patient, and it is thusdifficult for a medical practitioner prescribing electro-stimulationtreatment to control the treatment when the patient is away from aclinic.

Other known electro-stimulators include microprocessor based units, butthese have a problem that conventionally, specialised pre-programmingequipment needs to be used at the clinic to set the signal parameters.Such equipment is expensive and often difficult to use.

Specific embodiments of the present invention aim to provideelectro-stimulation apparatus which can be adjusted and preset by amedical practitioner, medical assistant or clinician without requiringof them electronic or computer literacy, and once set is tamper proof bya patient.

In the treatment of incontinence, it is known to use a vaginal or rectalelectrode comprising a moulded plastic plug which is insertable into thebody. Such plugs may be rigid, semi-rigid or of the expanding coil type.However, these known internal electrodes are uncomfortable andproblematic due to their fixed size, difficulty to insert and poorcontact with the body, producing uncomfortable sudden increases in pulsestrength. Subsequently, patients dislike such treatments and compliancewith the treatment is poor.

Surface electrodes of metal, metallised foil, carbonized rubber andother similar thin conductive plate materials are known. However, suchmaterials are insufficiently flexible and can be problematic causingdiscomfort, soreness and subsequently poor compliance to treatment. Theknown surface electrodes are unsuitably shaped and sized, andinsufficiently flexible for application over the perineal regionadjacent to the vaginal and rectal tracts.

Prior art cloth electrodes are known from U.S. Pat. No. 5,038,796 andU.S. Pat. No. 4,708,149. These electrodes are designed for functionalelectrical stimulation (FES) and the symptomatic treatrnent of suchafflictions as arthritic pain and back pain.

Pelvic Floor Exercises are a known treatment for exercising muscleswhich control the urinary function. Such exercises require levator animuscles to be contracted and relaxed regularly during the course of aday or over a period of many weeks, often months.

A known aid for such exercises comprises a pre-formed core of rigidplastics material. Such aids are provided in a set of graded weights,requiring the (female) patient to insert them into a vaginal tract, andretain them in position. However, this is difficult for many patients,because commonly the smallest available weight available is too heavy,or the size is incorrect. Insertion and renewal of the cores can beproblematic.

Another type of known device comprises a foam cushion, which is used toapply pressure at the bladder neck, keeping the bladder neck closedduring normal movement and exercise. However, such devices are notintended for, and are unsuitable for performing Pelvic Floor Exercises.The devices must be softened with water prior to use.

DISCLOSURE OF THE INVENTION

Specific embodiments of the present invention aim to address theproblems associated with conventional plug type electrodes, and theproblems encountered in the treatment of incontinence.

Specific embodiments of the present invention aim to provide an improvedPelvic Floor Exercise apparatus.

According to one aspect of the present invention there is provided aportable electrical stimulation apparatus for treatment of incontinencedisorders, comprising:

one or more electrodes for applying one or more electrical stimulationsignals to a patients body;

a signal generator for generating the electrical stimulation signal(s);

one or more conductive leads for connecting the signal generator to theelectrode(s), to deliver the electrical stimulation signal to theelectrode(s); and

a power supply,

characterised in that the apparatus includes an instruction storagemeans or a programming means for imparting a set of instructions to thesignal generating means, the signal generating means being responsive tothe instruction storage means or programming means that the generatedsignal adopts signal waveform characteristics selected in accordancewith said set of instructions.

Preferably at least one electrode is applied in the vaginal or analregion, and at least one electrode is a surface electrode to be appliedto a surface of the patients skin.

Preferably the waveform characteristics of the electrical stimulationsignal are not alterable by the patient, the waveform being determinedfrom normal neuronal activity of the patient and applied so as tosuperimpose the normal neuronal activity.

Preferably said instructions comprise instructions on the selection ofone or more of the following signal waveform characteristics:

pulse geometry type;

pulse width magnitude;

pulse train frequency;

pulse envelope type;

pulse envelope duration;

pulse envelope duty cycle;

treatment time;

signal intensity.

Preferably the pulse envelope duration is in the range 1 to 100,000microseconds.

Preferably the pulse train frequency is in the range 200 Hz to 5 MHz.

Preferably the envelope duty cycle is in the range 1 to 99%.

Preferably the number of pulses per each envelope is in the range 1 to20,000.

Preferably the pulse envelope is of a sinusoidal, square wave or sawtooth wave type.

Preferably the frequency with which the envelope occurs is in the range0.1 to 2,000 Hz.

The pulse envelope may occur at a time in the duty cycle, which israndom between successively generated envelopes.

Preferably the instruction storage means is a smart card.

Preferably the programming means is a personal computer.

Preferably the apparatus has a data logging means for recordinggeneration of the electrical stimulation signal, so as to provide arecord of how often the electrical stimulation signal has beengenerated.

According to a second aspect of the present invention there is providedan electrode characterised by being adapted to attach to the surface ofa perineal region, and an electrode characterised by being attached tothe lower sacral region. Said electrodes comprise a flexible conductivesubstantially sheet material.

Preferably, said electrodes are adaptable for use in the treatment ofincontinence. The flexible conductive sheet material preferablycomprises a woven or knitted cloth.

Said woven or knitted cloth may contain conductive fibres of stainlesssteel, gold or other electro plated precious metals.

Preferably said electrode further comprises a waterroof backing.

Preferably said electrode is attachable to a perineal region using aconductive adhesive gel.

Said electrode may have a stud fixing.

Preferably, said electrode has a pigtail type electrical connector.

Preferably a length of said electrode is in the range 20 to 100millimetres, and is suitably in the range 40 to 60 millimetres.

Preferably a width of said electrode is in the range 10 to 60millimetres, and is suitably in the range 20 to 40 millimetres.

The shape of the electrode may be such that it has one or more concaveperimeter portions. The electrode may have one or more convex perimeterportions.

Preferably, the electrode has an electrical plug connection, and mayhave an electrical connection lead.

The electrode may have an elongated centre portion of a first width andone or more protruding end portions of a second width, wherein saidsecond width is greater than said first width.

According to a third aspect of the present invention, there is providedan electrode which is adapted to be insertable into an anatomical cavityor tract, said electrode comprising a plug of a substantially expandableand/or compressible material.

The flexible and compressible construction of the internal electrode issuch that it can be compacted into tampon form for ease of insertion,hygiene and comfort. Once in place, the tampon will expand and provideelectrical contact with the vaginal/anal walls.

Said material may be a foam material.

Said material may be a polyvinyl formal foam (PVF) material.

Said material may be a paper or cotton material.

Said electrode may further cornprise a conductive sheath surrounding atleast partially said plug.

Said conductive sheath may be of a woven or knitted cloth.

Said electrode may further comprise a conductive lead adapted forcarrying a drive signal to said conductive material and for removingsaid plug from said cavity.

Said electrode may be adapted (or insertion of a rigid support member tosupport the electrode during insertion of said electrode into saidcavity or tract, said support member being removable once said electrodeis deployed therein within said cavity or tract.

Said electrode may be adapted for deployment in said cavity or tract byinsertion of a hollow tubular applicator containing said electrode incompression, in to said cavity or tract, followed by subsequent removalof said applicator from the cavity or tract, allowing expansion of saidelectrode within said cavity or tract.

According to a fourth aspect of the present invention there is provideda tampon electrode for insertion into the vagina or anus of a patient,the electrode comprising:

an outer sheath having a conductive outer surface for imparting anelectrical stimulation signal to the vaginal or anal wall; and

a conductive lead for sttpply of the electrical stimulation signal tothe electrode;

characterised in that the ottter sheath is expandable and contractiblesuch that the sheath can be inflated or deflated whilst in position inthe vagina or anus.

Preferably the electrode has a rigid inner member around which the outersheath is arranged, such that when the electrode is in the deflatedcondition, the rigid inner member lends the electrode sufficientrigidity so as to enable the electrode to be pushed into the vagina oranus for insertion therein.

Preferably the electrode has a fluid supply tube connected thereto fordelivery of a pressurised fluid to the electrode for inflation thereof.

Preferably the electrode is inflatable by an increase in air pressurewithin the outer sheath.

Preferably the outer sheath is of an elastic material.

Preferably said elastic material is a silicon rubber.

Preferably the conductive outer surface comprises a woven or knittedconductive cloth attached to the outer sheath.

According to a fifth aspect of the present invention there is provided asensing apparatus for sensing the condition of muscles in the vagina/oranus region, characterised by comprising:

a tampon electrode for insertion into the vagina or anus, the tamponelectrode capable of transmitting a pressure signal in response to anincrease in pressure exerted on the electrode bv the vaginal or analmuscles;

a pressure sensor means for sensing the signals the pressure sensingmeans producing an output dependent on the pressure exerted on theelectrode by the vaginal or anal muscles.

Preferably the pressure signal is a pneumatic signal or an hydraulicsignal, generated in response to pressure exerted on an expandable orcontractible electrode.

Preferably the electrode is inflatable and there are provided means forinflating the electrode.

The electrode may have a conductive outer surface for applying anelectrical stimulation signal to the vaginal or anal region, and thesensing apparatus includes a signal generator for generating theelectro-stimulation signal, and may include a condtuctive lead fordelivery of the electrical stimulation signal from the signal generatorto the electrode.

Preferably the apparatus has an electro-myographic or perineometersensor, which receives an electrical signal from the conductive outersurface of the electrode via the conductive lead, the signal generatorbeing arranged to produce an electro-stimulation signal in response toan output from the electro-myographic or perineometer sensor.

The apparatus may be adapted for use as a means of facilitation ofmuscles in the vaginal region or anal region.

Preferably the apparatus has a display and a data recording means.

The present invention may provide a multiplexed combination oftranscutaneous surface electrodes and/or internal vaginal/analelectrodes. The electrical characteristics of the said electrodes areprovided by woven or knitted conductive fabric which ensures uniformcurrent distribution and maximum comfort and hygiene.

The invention may provide a pulse generator which is convenient andsimple for the patient to operate. Preferably, the pulse generatorincorporates a data logging system to record patient compliance totreatment. Multiplexed pulse parameters can be preselected by the clinicfor specific treatments by insertion of the specially preprogrammedSmart Cards such as those using the PCMCIA Interface Standard.

Treatment parameters may be down loaded from a PC into an integralmemory using specially prepared software which initiates the specificparameters according to a patient's case history and symptoms.Preselected parameters loaded into the pulse generator are not availableto or adjustable by the patient and which ensures strict compliance tothe specific treatment regime.

Pulsed currents are delivered by the pulse generator, via thetranscutaneous conductive surface electrodes which have specificanatomical placement to stimulate the dorsal and perineal branches ofthe pudendal nerve as they arise above the lower facia of theuro-genital diaphragm.

Pulsed currents may also be applied directly to the fibres of thelevator ani muscle through the vaginal or anal walls using the tamponelectrode. Pulsed currents may also be applied via a combination of thetampon and the surface electrodes to direct the current to specificmuscles/nerve groups.

The present invention may provide for such pulsed currents to besupplied in variable frequency envelopes which are concomitant withnormal neuronal activity determined from similar, but healthynerve/muscle groups. The effect of such specific treatment currents isto re-establish neuronal motor and sensory control and to increase thepopulation and fatigue resistance of the type I postural muscle fibreswhich are responsible for uretheral and anal closure.

Provision is also made within the preset parameters to strengthen thetype II muscle fibres responsible for additional effort, support andreflex closure during physical stress conditions.

The present invention may also provide for an inflatable tamponelectrode which can be used A) to apply the preset treatment parametersthrough the vaginal and/or anal walls, or B) as an electromyographicperineometer sensor to measure improvement achieved by the treatment andto provide encouragement for the patient to continue, or, C) as a meansof Facilitation to provide a combined voluntary and F.E.S induced muscleexercise programme.

Any of the said tampon electrodes can be used solely or in combinationwith the cutaneous electrodes.

The invention includes a portable electrical stimulation apparatuscomprising;

a signal generating means for generating an electrical signal; and

a preset instruction means, or a preset programming means, for impartinginstructions to the signal generating means.

wherein the signal generating means is responsive to the programmingmeans such that the generated signal can adopt characteristics selectedin accordance with said instructions.

Preferably, said programming means comprises a memory storage devicepre-programmed with said instructions.

Preferably, the memory storage device is detachable from said signalgenerating means.

Preferably, the apparatus has a plurality of said memory storagedevices, each substitutable for one another.

Each individual said memory storage device may be pro-programmed with adifferent set of instructions to each other memory storage device.Preferably, the apparatus further comprises a signal processing meansfor producing an electrical drive signal in accordance with any of saidinstructions. Said memory storage device may be permanent within theapparatus and can be programmed via a personal computer using softwareroutines which generate the said parameters from data input in respectto patient history and symptoms. The said software may comprise userfriendly windows with relevant prompts for every aspect of treatment tobe considered. A user option is provided to allow final parameteradjustment within predetermined limits. Thus a set of said memorystorage devices may be provided, each containing instructions to thesignal generating means for generating a signal suitable for treatmentof a particular disorder.

The apparatus may have a patient-adjustable means of varying theintensity of an electrical drive signal to an electrode.

According to a further aspect of the present invention, there isprovided a portable electrical stimulation apparatus comprising a drivesignal generation means and recording means for recording data regardingoperation of the drive signal.

Said recorded data may include the frequency and/or duration of a timeperiod in which said drive signal is actively conducted through livingtissue. This may provide a strict compliance record of stimulationapplied to the body. Said recording will not register if electrodesbecome detached or short circuited.

Said recording means may be interrogatable to display parts of saiddata. Said recording means may be interrogatable by a personal computervia a data port, said data port comprising part of the apparatus.

Said recording means may also be embodied within a Smart Card or FlashCard with random access memory (RAM) or non volatile memory. Saidstorage device will preferably be portable and be able to transmit andreceive stored data berween a personal comuputer and the signalgenerator.

According to another aspect of the present invention, there is providedan electrode which can be attached to another part of the externalanatomy such as a buttock. This indifferent electrode would preferablybe used with monophasic or a symmetrically balanced pulse geometry wherestimulation at the indifferent is unimportant to the treatment.

As such, this electrode may be of arbitrary shape and size, but willpreferably be of twice the conductive surface area to that of theperineal electrode to provide a wider dispersal of the current at theindifferent electrode position over the sacral plexus.

Said indifferent electrode is preferably of specific shape and size tomould comfortably over the sacral spine, spinous processes, S2, S3 andS4. Said position is preferable to provide stimulation using balancedbyphasic pulse geometry over the sacral nerve routes from where theurinary and faecal control nerves originate.

The invention provides for an electrode adapted to be insertable into ananatomical cavity or tract, said electrode comprising a core of asubstantially expandable and/or compressible material.

Said material is preferably substantially deformable and resilient.

Preferably, the electrode further comprises a conductive sheathsurrounding at least partially said core.

Preferably, said conductive sheath is of a woven or knitted fibre, forexample stainless steel, gold or other electro-plated precious metal.

Preferably, the tampon electrode further comprises a conductive leadadapted for carrying a drive signal to said conductive material and forremoving said electrode from said cavity.

The core may have a hollow passage for the insertion of a rigid memberfor supporting the core during insertion into the cavity or tract.

Said tampon electrode may have a first said conductive sheath and asecond said conductive sheath. said sheaths being electrically isolatedfrom each other, said sheaths having respective first and secondelectrical connection means thereto.

Said first and second sheaths may be driven by respective first andsecond driving signals.

Said first and second driving signals may be substantially identical ormay be substantially dissimilar to each other.

The invention includes use of a said tampon electrode having first andsecond conductive sheaths in F.E.S. treatment of incontinence.

The invention provides for a plug having a core of a resilientdeformable material for insertion into a human vaginal or rectal tract.

Preferably, said core material ohardnd electrode or plug has a Shorehardness of below 45.

Suitably, said material has a Shore hardness of less than 30.

Said material may be a foam material, for example a polyvinyl formalfoam (PVF) material. Said material may be a paper or cotton material.

An electrode or plug according to the fourth or fifth aspects may beadapted for insertion of a rigid support member to support the electrodeduring insertion of said electrode into said cavity or tract, saidsupport member being removable once said electrode is deployed thereinwithin said cavity or tract.

A said electrode or plug according to the fourth or fifth aspect may beadapted for deployment in said cavity or tract by insertion of a hollowtubular applicator containing said electrode in compression into saidcavity or tract, followed bv subsequent removal of said applicator fromthe cavity or tract, allowing expansion of said electrode within saidcavity or tract.

Preferably an electrode and/or plug according to the fourth or fifthaspect has a length in the range 30 to 100 millimetres.

Suitably, said length is in the range 45 to 65 millimetres.

Preferably, the electrode and/or plug has a width or diameter in therange 10 to 40 millimetres.

Suitably, the width is in the range 20 to 30 millimetres.

The invention provides for an inflatable tampon electrode. Saidinflatable tampon electrode may have a gossamer, non-conductive outersheath. Said outer sheath may be a silicon rubber. Said outer sheath mayincorporate an integral conductive band. Said conductive band may be asubstantially sheet material.

Said sheet material may be of woven or knitted conductive cloth. Saidconductive cloth may be woven or knitted fibre, for example stainlesssteel, gold or other electro-plated precious metals. Said conductivecloth may extend internally to form the connecting means to a pulsegenerating apparatus. Said connecting means may also provide a means ofobtaining electromyographic (EMG) readings and recordings.

Said connecting means will pass through a semi-rigid tube which may beused to insert the tampon prior to treatment. Said semi-rigid tube willprovide a means to pass air into the outer flexible sheath such that theouter sheath may be inflated until it is in contact with the internalwalls of the patients body cavity. Said air tube and electricalconnection is preferably connected to a monitoring and stimulatingapparatus, preferably incorporated into the pulse generator.

Said apparatus may comprise an air pump to inflate the tampon, and apressure sensor to monitor internal air pressure and to cut off the airsupply to the tampon when a predetermined level of air pressure isreached. Said sensor may determine a volumetric inflation required toattain a resting tone pressure of the muscles surrounding the inflatablesheath and may detect any increase caused by contraction of thesurrounding muscle. Such a measurement may indicate a patient's progressand improvement due to the main stimulation treatment.

Said sensor may be used to facilitate stimulating pulses in response topressure increase due to voluntary muscle contraction. Said stimulatingpulse will cause further muscle contraction and further aidstrengthening. Through this facilitation. the patients voluntary musclestrength will be enhanced by muscle stimulation. Said pulse parametersmay be any of those previously described. Said apparatus may store datain a memory for later analysis. Said apparatus may provide a visualdisplay which a patient may use to work to a daily exercise/facilitationroutine with specified targets and visual achievements.

The invention incit,des a compilation of an electro-stimulator apparatusas above, a selection of stimulator electrodes as above, a selection ofprogramming modules each programmed for a different type of treatment, aplurality of treatment instruction cards corresponding with the modulesand giving instructions for the administration of treatment by thepatient and/or clinician in accordance with the mo\, and an instructionguide on the use of the apparatus, which may also be incorporated in theSmart Card.

The invention includes a method of treatment of incontinence usingelectrical stimulation of a perineal region by a flexible substantiallysheet material electrode.

The invention includes a method of treatment of incontinence usingPelvic Floor Exercises and Bio \feedback using an electrode or plug asdescribed in the fourth or fifth aspects.

The invention includes a method of monitoring a patients' progress, anddetermining an improvement in pelvic floor tone and strength.

DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, and to show how the samemay be carried into effect, reference will now be made, by way ofexample, to various specific embodiments of the invention as shown inthe accompanying diagrammatic drawings in which:

FIG. 1 shows a portable \rve module according to a specific embodimentof the present invention or driving an electrode;

FIG. 2 shows a schematic circuit diagram of the drive module;

FIG. 3 shows in plan view a first cutaneous electrode pad according to aanother specific embodiment of the present invention;

FIG. 4 shows in plan view a second cutaneous electrode pad according toa further specific embodiment of the present invention;

FIG. 5 shows in plan view a third cutaneous electrode pad in accordancewith vet another embodiment of the present invention;

FIG. 6 shows in plan view an electrode for positioning on the sacrum ofa patient, according to another embodiment of the present invention;

FIG. 7 shows an electrode for positioning in the perineal region,according to another embodiment of the present invention.

FIG. 8 shows a construction of the embodiments of FIGS. 3 to 7;

FIG. 9 shows one way of positioning the sacral electrode of FIG. 6 on apatients skin;

FIG. 10 shows one way of positioning the perineal electrode of FIG. 7 ona patients skin;

FIGS. 11 to 19 show various prior art pulse geometry components;

FIG. 20 shows part of one example of an electrical stimulation drivesignal according to the present invention;

FIG. 21 shows as an example according to the present invention, a partof an electrical stimulation drive signal in the form of a preprogrammedpulse train;

FIG. 22 shows as an example according to the present invention, a partof an electrical stimulation drive signal having a bi-phasic pulse trainenvelope;

FIG. 23 shows as an example according to the present invention, a formof an electrical stimulation drive signal having a bi-phasic pulse trainand a pulse train envelope which is modulated;

FIGS. 24 to 26 show the preselected pulse geometry delivered in variouspulse envelopes timed over predetermined execise and relax periods, thevoltage intensity in the initial and final time periods within eachexercise and relax phase may also be ramped up or down for additionalpatient comfort.

FIGS. 24 shows as an example according to the present invention, a partof an electrical stimulation drive signal having uniform fixed rateenvelopes;

FIG. 25 shows as an example according to the present invention, a formof electrical stimulation drive signal having a randomly generatedenvelope;

FIG. 26 shows as an example according to the present invention, a formof electrical stimulation drive signal having sequentially generatedenvelopes;

FIG. 27 shows a first insertable electrode for internal use, accordingto an embodiment of the present invention;

FIG. 28 shows a second insetrobie electrode according to anotherembodiment of the present invention;

FIG. 29 shows a third insertable electrode according to anotherembodiment of the present invention;

FIG. 30 shows a fourth insertable electrode according to anotherembodiment of the present invention;

FIG. 31 shows a fifth insertable electrode according to anotherembodiment of the present invention;

FIG. 32 shows a construction of part of an insenable electrode accordingto an embodiment of the present invention;

FIG. 33 shows an inflatable electrode according to a specific embodimentof the present invention; and

FIG. 34 shows a sensing apparatus according to a specific embodiment ofthe present invention.

BEST MODE FOR CARRYING OUT THE INVENTION

An electro-stimulation apparatus according to a specific embodiment ofthe present invention comprises a drive module and a stimulationelectrode arranged to be driven bv the drive module.

Referring to FIGS. 1 and 2 of the accompanying drawings, a drive unit 1comprises a portable case 2 which contains an electric battery powersupply, 4, and electronics (not shown in FIG. 1). The drive unit has adetachable instruction storage or programming means such as a smart card3 and further comprises a clip for attaching the drive unit to an itemof clothing, for example a belt.

The smart card 3 is attachable to the electronics of the drive unit 1via a connection socket 5 and is detachable such that it can be replacedby a substitute Smart card.

The drive unit further features an intensity control 13 for controllingthe intensity of the drive signal to the stimulator electrode, theintensity control being of a type which can be altered by the patient,and an indicator lamp 14 to indicate when the drive signal is operatingand/or whether the battery is charged. A liquid crystal display (LCD)may also be provided to show the status of the device.

Referring to FIG. 2 of the accompanying drawings, a schematic diagram ofthe electronics of the drive unit of FIG. 1 is shown. The electronicscomprises the socket 5 for accepting the Smart Card 3, a battery powersupply 6 for supplying power to the electronics, a pulse generator 7, anoutput pulse shaper 8 for modifying the output of the pulse generator 7and outputting a drive signal, a plurality of output sockets 9 connectedto the output pulse shaper 8 and providing an output path for the drivesignal, an intensity control 13, which is, for example a thumb wheelvariable resistor, a real time logger 10 for recording parameters of theoutput of the pulse generator and/or drive signal and an externalconnector 11, for example a serial port through which the real timelogger 10 can be interrogated periodically using separate interrogationequipment, for example a personal computer, and the batterycharge/signal output indicator 14.

The output socket 9 is connectable to a stimulator electrode, which isdriven by the drive signal via an output electrode lead 12 from thedrive unit.

The electrode lead 12 is preferably of a high flex material such assilicon rubber, having standard 2 mm plug pins or press-stud typefasteners for connecting to the stimulator electrode.

The Smart Card may be either pre-programmed or programmable using astandard PC. The smart card module could be replaced by some otherinstruction storage or programming means, e.g. an audio cassette, or aninternal ROM programmable externally of the drive unit. Hereafter, forconvenience, the instruction storage or prograrnming means will bereferred to as a Smart card.

In use, the drive module operates as follows. The pulse generator,produces a pulse signal in response to programmed instructions stored inthe smart card 3. The pulse signal is then modified by the output pulseshaper 8 in accordance with the instructions stored in the Smart card. Adrive signal appears at the output of the pulse shaper, on the outputlead 12, and is supplied to the output socket 9 connected to thestimulation electrode.

Each smart card may be supplied either pre-programmed or programmableusing a standard personal computer. Each pre-programmed smart card isclearly marked with the parameters of the drive signal which the card isprogrammed for producing, together with the type of therapeutictreatment to which these parameters relate. For example, a smart cardmay be marked with the following information, and programmed accordinglywith instructions for generating electrical stimulation drive signalhaving corresponding waveform characteristics.

Treatment, URINARY STRESS INCONTINENCE

Pulse geometry-square biphasic

Pulse width--200 μsecs

Pulse envelope frequency--Random 5-40 Hz

Pulse envelope--100 msecs

Exert/relax--8 see cycle 50% duty cycle

Treatment time--2 hours

Intensity--0-30 Ma.

In other Smart cards for other treatments, variations upon the abovedrive signal characteristics may be made. For example any of a number ofdrive signal characteristics may be varied.

The real time logger 10 records details of the pulse signal output fromthe pulse generator 7 through normal biological body impedance.Stimulation pulses generated during electrode disconnection or shortcircuit will not register on the data logger or Smart Card. Complianceof the output drive signal can be monitored and checked againsttreatment prescribed by a clinician. The recorded data shows whether atreatment has been administered on a regular basis, without anyparameters of the drive signal being tampered with by the patient.

In use in a clinical situation, a complete electro-stimulator apparatuscomprises a selection of stimulators, a selection of modules eachprogrammed for a different type of treatment, treatment instructioncards corresponding with the modules and giving instructions for theadministration of treatment by the patient and/or clinician, a batteryrecharger, (where required) and a full instruction guide on the use ofthe apparatus.

FIGS. 3 to 7 of the accompanying drawings show various embodiments oftranscutaneous electrode pads suitable for perineal application. Suchelectrodes are suitable to be driven by the drive unit described withreference to FIGS. 1 and 2.

The electrode pads are constructed from woven or knitted electricallyconductive cloth, mounted on a thin flexible and waterproof material andcoated in a self-adhesive conductive gel. The conductive gel is of aknown prior art type, and in one version is formulated to be adjustablein adhesive strength by the addition of water.

The first embodiment electrode 50 shown in FIG. 3, a stud fastener 51and a pigtail cable 52 having a socket 53 for connection to for examplethe output socket 9. Where a pigtail connection is used the conductiveelements of the cable 52 may be extensions of the woven material of theelectrode 50. Connection of the conductive elements to the plug 53 maybe by moulding the elements into the plug, by sewing the elements intothe plug after moulding, by adhesive bonding using a conductive adhesiveor by ultrasonic welding. Similarly, the conductive elements of thecable 52 may be adhesively bonded to, or ultrasonically welded to, orsewn into the woven material of the electrode 50.

The electrode is shaped as shown, having an elongate strip 60 of a firstwidth having projections 62 of a second width at each end. A perimeter63 has one side 64 which is convex in shape, and one side 65 which isconcave.

A preferred maximum length for the electrode shown in FIG. 3 is of theorder 50 mm, and preferred widths are in the range 20 to 40 mm,preferably in three sizes of widths 20 mm, width 30 mm and width 40 min.

Referring to FIG. 4, a second embodiment electrode has a plug 51 or apigtail 52, 53 similarly as above, and is of similar maximum dimensionsas the first electrode.

A third embodiment electrode as shown in FIG. 5 is of a "kidney" typeshape, has either a plug 51 or pigtail 52, 53 and is preferably ofexternal maximum dimensions of the same order as the electrode of FIG.3.

Although the above dimensions are preferred, it is anticipated that somevariation in dimensions of up to plus or minus 100% may suit the widevariety of naturally occurring sizes and shapes of the perineal body.

Referring to FIG. 6 of the accompanying drawings, an electrode suitablefor fitting to the sacral region is shown. The electrode is of knittedor woven conductive cloth, similar to the above mentioned electrode, andis of a generally truncated triangular shape in plan view. The electrodehas a base width of around 67 mm, a height of around 70 mm and a apexplateau region 200 of width around 15 mm. The plateau region has adipped portion for placement of a finger to aid in positioning of theelectrode over the sacrat spinous processes of S2, S3 and S4. Theelectrode is provided with a pigtail electrical contact lead 201 oflength around 54 mm, terminating in a plug connector 202.

Referring to FIG. 7 of the accompanying drawings a surface electrodesuitable for fitting to the perineal region comprises a sheet ofconductive woven or knitted material in the shape of an hour glass 205,having a length of around 50 mm and a width of around 40 mm. The neck ofthe hour glass shaped electrode is preferably of width around 16 mm, anda pigtail lead of length around 92 mm is provided. Preferably, thepigtail lead is attached at the side of the electrode as shown in FIG.7, for hygiene and ease of fitting.

Referring to FIG. 8, a structure of an electrode pad is shown. The padcomprises a woven or knitted conductive cloth 80, coated in a conductiveadhesive gel 81. The adhesive gel may be of a known type, The cloth 80is coated by a water proof backing 82, which is for example a plasticssheet material. The water proof backing is attached to the cloth by anadhesive laver 83. A conducting wire 84 in the form of a pigtail lead iselectrically and physically attached to the cloth 80. A drive signal istransmitted along the pigtail to drive the electrode. The electrode padhas a press-stud 85, which may be used for aiding placement of the padusing a strap or the like. The stud may be electrically conducting andcontact the cloth 80 such that a drive signal may be supplied via thestud in addition to or in alternative to the pigtail lead 84.

Referring to FIG. 9 of the accompanying drawings, placement of thesacral surface electrode of FIG. 8 is shown schematically, incombination with a further surface electrode 300 placed on a buttock ofthe patient, the further electrode being an indifferent electrode.

Preferably the sacral surface electrode is positioned over the sacratspine S2-S4. Placement of the indifferent electrode is optional.

Referring to FIG. 10 of the accompanying drawings, the perineal surfaceelectrode as described with reference to FIG. 8, is shown positionedover the perineal body of a patient to provide stimulation to the dorsaland perineal branches of the pudendal nerve 301. The sacral electrode302 is also shown in position.

Any of the above electrodes may be reusable or disposable.

Use of the apparatus described with reference to FIGS. 1 to 10 will nowbe described, referring also to FIGS. 11 to 26.

In use, for treating urinary incontinence, one or more of the aboveelectrodes are deployed over a perineal body between (in a female) thevagina and the anus. It is important that the electrode remains firmlyin position during normal movement and is flexible enough to accommodatesuch movement. The use of a knitted or woven conductive material with aconductive adhesive gel in an electrode of shape specifically adaptedfor the perineal region may provide the necessary comfort and securefixing to allow treatment of incontinence by a cutaneous electrode to beacceptable to the patient.

The electrical stimulation drive signal may be constructed as acombination of one or more signal per pulse geometries. Examples of suchsignal pulse geometries which may be selected according to instructionson the smart card are shown in FIGS. 11 to 19. For example FIG. 11 showsa simple Galvanic type wave form. FIG. 12 shows a simple sinusoidalwaveform. FIG. 13 shows a square monophasic waveform. FIG. 14 shows asquare waveform. FIG. 15 shows a square bi-phasic waveform. FIG. 16shows a pulsatile (asymmetric balanced) wave form. FIG. 17 shows aFaradic waveform. FIG. 18 shows a monophasic sawtooth spike wave form,and FIG. 19 shows a bi-phasic sawtooth spike, wave form.

The Pulse Width may be selectable from, for example, any one of 80, 160,200, or 320 μsec widths. The Pulse Envelope frequency may be selectedfrom any one of three types. Type one is a regular fixed frequency rate,for example 10 Hz. Type two is a sequential rate rising or falling froma preset starting frequency to a preset final frequency. Type three is arandomly generated frequency rate with pulse separations occurringrandomly between preset start and end frequencies. The pulse envelopeduration may be selected from a range including for example 100, 250,500, 750, or 1,000 μsecs. The Exercise/Relax cycle is similarly variableand the initial and final intensity voltages may be adjustable toprovide a smooth ramp up and down for patient comfort. The overalltreatment time is variable and the intensity may be selectable from thefollowing ranges: 0-30 mA, 0-60 mA, or 0-100 mA.

Referring to FIG. 20 of the accompanying drawing, an example of aportion of a specific output drive signal waveform in accordance withspecific pre-programmed instructions is shown. The example showncomprises a square monophasic waveform having a pulse burst duration of100 μsecs and a frequency of 2 Khz. The pulse width is 80 μsecs and theperiod between bursts is 99 ms. The intensity (the height of the pulsein FIG. 11) is adjustable by the patient in the range 0-60 mA. Otherportions of the drive signal waveform may have a frequency in the range1 Hz to 2 KHz.

Referring to FIG. 21 of the accompanying drawings, a typicalpreprogrammed bi-phasic pulse train is shown. The pulse train comprisesa first pulse 500 of duration time T1, an inactive period 501 ofduration time T2, a second pulse 503, of an opposite sense to the firstpulse 500, and of duration time T3, and a second inactive time T4, thesecond inactive time being variable according to the frequency selected.The times T1, T2 or T3 are variable but typically may be T1=200 μsecs,T2=100 μsecs, T3=200 μsecs.

Referring to FIG. 22, a preferred form of bi-phasic pulse is shown in anenvelope train. The envelope duration is preferably in the range 100 to1,000 μsecs, and N pulses per envelope are provided, N preferably beingin the range 1 to 1,000. The envelope frequency FR2 can be sequential,random or fixed and is typically in the range 0.1 to 100 Hz. The periodbetween repetitions of pulse packets. FR1 typically corresponds to afrequency of 500 to 5,000 Hz.

Referring to FIG. 23, a pulse train having a modulated envelope isshown. The modulation of the pulse train envelope can be any suitableshape. The duty cycle of the envelope, within the envelope perioddefined by the envelope frequency FR2, is preferably in the range 1 to99%.

Referring to FIG. 24 of the accompany drawings, an example of a uniform(fixed) rate envelope is shown. A preselected pulse geometry of pulsesbeing spaced apart by 2 μsecs, with a preselected pulse geometry ofeither a monophasic or bi-phasic, and either a square or randomcharacteristic is selected.

FIG. 25 shows a random generated envelope sequence in which pulseswithin the envelope are randomly spaced apart from each other, in thisexample by a period between a first and second pulse being 2 μsecs, theperiod between the second and third pulse being randomly selected as 10μsecs, the period between the third and fourth pulse being randomlyselected as 6 μsecs, between the fourth and fifth pulse the time israndomly selected as 2 μsecs, and between the fifth and sixth pulse thetime is randomly selected as 4 μsecs. In a succeeding pulse envelope,the times between the pulses within the envelope are randomly selectedagain, and are different from those in the first envelope shown.

Use of a randomly generated pulse train within a fixed pulse envelopemay have an advantage that the human body does not become acclimatisedto the particular form of treatment. The patients body may maintain itsresponse to the treatment, which has no predictable pulse pattern withinthe pulse envelope, over an indefinite period, without significant lossof effectiveness.

Referring to FIG. 26 of the accompanying drawings, a set of sequentiallygenerated envelopes are shown in which the exercise phase (i.e. theperiod occupied by the pulse envelope), and the relax phase arevariable. This is equivalent to varying the position in time of thepulse envelope within the duty cycle. In the example shown, within thepulse envelope, the pulses are ordered such that the second pulse isspaced from the first pulse by a time of 2 μsecs, the time elapsedbetween the second and third pulses is 4 μsecs, the time elapsed betweenthe third and fourth pulses is 6 μsecs, and the time elapsed between thefourth and fifth pulses is 8 μsecs. This pattern is repeated insuccessive sequentially generated envelopes.

Hereinabove, FIGS. 24 to 26 have shown the exercise/relax cycles with aconstant amplitude at start and finish. This may be replaced with agradual ramp up/down over a preselected period similar to that shown inFIG. 24.

Various other electrodes, of the insertable type, will now be described.

Referring to FIG. 27 of the accompanying drawings, a first insertableelectrode comprises an inner core moulded from a resilient anddeformable material such as a foam, or paper/cotton fibre 100 and anouter conductive sheath 101 of knitted or woven conductive fibre, forexample stainless steel fibre, or metallized plastic fibre. The outerconductive sheath surrounds the inner core 100. Individual fibres of theouter conductive sheath are gathered into a thread 102 and connected viaa crimp connection 103 to a flexible pigtail connector wire 104 of, forexample, silicon rubber coated wire. The flexible pigtail connector wirehas at one end a plug 105 for connection to a drive u\.

The material of the inner core 100 and the outer conductive sheath 101are deformable to allow compression and insertion of the electrode intoa hollow tubular applicator (not shown). A suitable core material has aShore hardness of below 45, and is deformable enough so as to becompressed to 75% or less of its unrestricted size. In an electrode ofdimensions suitable for insertion into a vaginal or rectal tract, asurface of the foam is preferably depressible by at least 1.5 mm.

Biocompatible fibres may be used in the construction. For exampleBiocompatible Polyvinyl Formal (PVF) foam, cotton or paper materials.

The electrode may be manufactured as a single moulded flexibleconductive foam or as a moulded PVF foam plug surround by flexibleconductive woven or knitted cloth sheath. In this latter embodiment, thesheath may be incorporated during the moulding phase of manufacture ormay be fitted after moulding.

The electrode may alternatively be manufactured as a moulded PVF foam asabove, but with an inner plug manufactured from fibrous paper or cottonmaterial.

In use, the applicator, containing the electrode, is inserted intoeither a vaginal or anal tract, to position the electrode therein. Theapplicator is then withdrawn, without moving the electrode. Oncereleased, the foam material of the electrode expands to provide closecontact with an internal wall of the vaginal or anal tract. Alubricating gel may be used during insertion and/or extrusion of theapplicator to aid deployment. The gel may be conductive.

The electrode may be washable or disposable.

Referring to FIG. 28, a second insertable electrode comprises anelongate substantially cylindrical core of a resilient deformablematerial 100 as aforementioned with reference to FIG. 27, having atubular band of conductive material 101 which surrounds and constricts amid portion 109 of the core. At either end of the band. portions of thecore 110, 111, which are unrestrained by the band 101 relax to adopt anuncompressed diameter greater than the diameter of the constricted midportion of the core 109.

The mid portion 109 of the core may be further compressible bycompressing the conductive material 101, but is restricted fromsubstantial expansion to a fully relaxed state by the band 101.

The tubular band is of length in the range 15 to 20 mm, the overalllength of the core being suitably in the range 50 to 60 mm and therelaxed diameter of the core being in the range 20 to 30 mm. Thesedimensions may be varied to accommodate natural anatomical variations.

The second electrode has an hollow tubular passage 108 centrally, foraccommodating a rigid rod centrally in the core. Using this rod, theelectrode may be pushed into the tract without the need for an enclosingapplicator as described with reference to FIG. 28. In this mode ofdeployment, the end portions 110, 111 of the core, and/or the midportion 109 may be squeezed during insertion, and then expand when inplace in the tract.

However, the embodiment is not restricted to this mode of deployment andmay be inserted in a hollow applicator as aforementioned with referenceto FIG. 28, and may retained in the tract during removal of theapplicator by the insertion of the rod in the hollow passage 108. Therod is subsequently removed.

The second insertable electrode has a contact lead 104 and plug 105 formaking electrical connection to the conductive material 101 and for usein removing the electrode from the tract.

Referring to FIG. 29, a third insertable electrode is of similarconstruction to the second electrode, but, a tubular band 130 ofconductive material of length in the range 6 to 12 mm is provided.

Referring to FIG. 30, a fourth insertable electrode is of similarconstruction to the above mentioned first insertable electrode, of FIG.28, however, in the fourth insertable electrode, a hollow passage 108 isprovided in the core 131 for insertion of a rigid rod, similarly asdescribed with reference to the second insertable electrode.

Referring to FIG. 31, a fifth insertable electrode comprises a core offlexible material 100, similarly as described with reference to FIG. 29,and first and second tubular bands 150, 151 each of a conductivematerial as described hereinabove with reference to FIGS. 18 to 21. Eachconductive band 150, 151 is connected to a respective first and secondconductor leads 152, 153, in a manner as hereinabove described.

Preferably, the conductive bands are each of length 6 mm or thereabouts,and separated by a distance of 8 mm, although these dimensions and layouts are not restrictive and may be varied. During treatment, theinflatable tampon electrode may be used periodically to monitor progressand provide encouragement for the patient to continue.

The fifth electrode may be deployed as previously described hereinabovewith reference to FIG. 28.

In use, the fifth electrode may be electrically driven via the first andsecond leads 152, 153 by respective first and second drive signals. Thefirst and second drive signals need not be identical, and preferablyhave different parameters. Such an electrode may be suitably useable inFES treatment.

Referring to FIG. 32, a structural portion of an insertable electrode isshown. Such a structure may be incorporated into any one or more of theinsertable electrodes as described with reference to FIGS. 27 to 31 ashereinabove described.

The structure comprises a core of foam material 100, such as hereinabovedescribed, an electrically insulating backing material 140, for examplea sheet material, an adhesive layer 141, and a conductive fibre material142. The insulating backing material and adhesive layer are sandwichedbetween the conductive material and the core.

A connecting lead 143, in the form of a pigtail wire, is incorporatedinto the structure, making electrical contact with the conductivematerial 142. The connection is of sufficient strength to enable theinsulating electrode to be pulled using the connecting lead. without theconnecting lead coming loose from the structure. Additionally, the leadmay be woven into or otherwise attached to the conductive fibre 142,similarly as herein described with reference to cutaneous electrodes.

Referring to FIG. 33 of the accompanying drawings, an inflatable tamponelectrode for insertion into the vagina or anus of a patient is shown,the electrode having an outer sheath 600, of a rubber silicon material,the outer sheath being inflatable or deflatable by air which is pumpedin through a delivery pipe 601 and a rigid internal member 602, and awoven or knitted conductive cloth 603 bonded to the outer surface of therubber sheath 600. The conductive sheath is connected to externalsensing apparatus by an electrically conductive lead wire 604 which runsthrough the centre of the rigid member and the hollow air delivery pipe601.

Referring to FIG. 34 of the accompanying drawings, the other end of thedelivery pipe 601 and connecting lead 604 enter a sensing apparatus 700.The sensing apparatus comprises a pressure sensor 701, a pulse generator702, an electromyographic sensor 703, an air compressor 704, and adisplay and data recorder 705.

The tampon electrode of FIG. 33 and the sensing apparatus of FIG. 34 areused in various modes as follows. Firstly, the air compressor is runcontinuously to inflate the inflatable tampon electrode of FIG. 33. Apatient is encourage to squeeze the tampon electrode, and changes in airpressure are detected by the pressure sensor 701 and displayed by thedisplay and data recorder 705. Thus a measure of the strength of apatient's muscles can be determined by the read out on the display anddata recorder 705. Alternatively, the patient can be asked to squeezethe electrode, and the number of strokes of the air compressor countedin order to reach a predetermined pressure. This number of strokes willalso give a measure of the condition of the patient's muscles.

In a facilitation mode, the patient is encouraged to squeeze theelectrode, which is inflated by the air compressor 70, when squeezing ofthe electrode is detected by either a pressure difference monitored bythe pressure sensor 701, or by a difference in the amount of work theair compressor needs to do to keep the electrode inflated, then thepulse generator generates a signal in response to either of these twodetected parameters and transmits this along the conductive lead 604 toelectrically stimulate the muscles. This results in further contraction,aiding the patient in their squeezing action. Additionally, the pulsegenerator may be activated in response to an output from theelectromyographic or perineometer sensor 703.

Any one or more of the above described internal electrodes can be usedto perform Pelvic Floor Exercises. The preferred method is by using theembodiment of FIG. 33 in conjunction with Bio feedback and FacilitatedElectrical Stimulation. In such exercise, a (female) patient, practicessqueezing exercises by squeezing and relaxing against the resilience ofthe electrode.

The patient exercises by working muscles against the resilience of thecore material, rather than by attempting to keep the core in situ.

Variations in the resilience and deformability of the core material 100maybe made to suit various exercises. A series of electrodes may beprovided, each electrode being of a progressively increaseddeformability and/or resilience to provide a means of performing aprogramme of progressively more advanced exercises.

In the above described embodiments of insertable electrodes, the outerconductive sheath may be completely conductive over the whole of itssurface, or may comprise one, two or more conductive bands incorporatedtherein. In either case, the conductive material contacts the wall ofthe tract to deliver an electrical signal thereto. The sheath may beconstructed from flexible woven or knitted cloth or may be of stitchedconstruction using conductive fibres. The sheath may be sewn or bondedto the core.

In each embodiment of the internal electrode, the connecting pigtailwires are preferably sewn or crimped to the sheath to be used forpulling the electrode during removal from the cavity.

A main advantageous feature of the various of the above embodiments maybe an ability to multiplex facets an individual patient's treatmentprogramme. For example, in Stress incontinence, the patient may follow aparticular set of preset instructions for NTS treatment which would beintended to restore a pudendal nerve function and regenerate type I slowmuscle fibres.

The treatment can be applied via a cutaneous perineal electrode and anarbitory indifferent electrode positioned on the buttock, thigh orabdomen, with the treatment pulse preset to a specified set ofparameters by the smart card selected for this aspect of treatment.

In later weeks the treatment may require that the type I slow fibresrequire additional strengthening and the electrode system could then bechanged for NMS treatment, by passing the pulse between the singlebanded tampon electrode and either a cutaneous perineal or arbitoryindifferent electrode. The electrical parameters for the electrode drivesignals could be provided in accordance with appropriate instructionscontained in a second smart card.

At the end of the treatment, it may then be preferable to add to thestrength of the type It fast fibres which may best be achieved by FEStreatment, applied using a single double banded tampon electrode drivenby a new selected drive signal in accordance with new instructionscontained in a third smart card.

The final part of the treatment may include use of the bio-feedbackfacility.

Thus, a flexible treatment apparatus and system may be provided, using asingle piece of equipment. In contrast, using prior-art systems, apatient would possibly only receive one of the aforementioned modes oftreatment, or alternatively, three separate sets of equipment would benecessary.

Specific embodiments of the invention may have an advantage of providingvariable combinations of pulse geometry, intensity ceilings and presettreatment parameters to suit, in addition to urinary or faecalincontinence treatment, therapeutic requirements includingTranscutaneous Electrical Nerve Stimulation (TENS), FunctionalElectrical Stimulation (FES), Neuro Muscular Stimulation (NMS), NeuroTrophic Stimulation (NTS), Interferential Therapy, Iontophoresis orGalvanism.

Specific embodiments of the invention may provide a versatile apparatuswhich provides a combination of electro-stimulation treatments availablein a single unit. The module may have an advantage of being easily setby a clinician to provide a prescribed electro-stimulation treatment,yet be tamper proof by a patient.

Various of the embodiments may have an advantage of being capable ofrecording details of the administration of a prescribed treatment suchthat clinician can periodically monitor such administration when thepatient is out of clinic.

The embodiments may advantageously provide an electro-stimulationapparatus which is portable by a patient, and can be preset to provide adrive signal having fixed parameters selected from a range of selectabledrive signal parameters.

Specific embodiments of the present invention may have an advantage ofproviding means of treatment for incontinence using a flexible sheetmaterial electrode.

The reader's attention is directed to all papers and documents which arefiled concurrently with or previous to this specification in connectionwith this application and which are open to public inspection with thisspecification, and the contents of all such papers and documents areincorporated herein by reference.

All of the features disclosed in this specification (including anyaccompanying claims. abstract and drawings), and/or all of the steps ofany method or process so disclosed. may be combined in any combination,except combinations where at least some of such features and/or stepsare mutually exclusive.

Each feature disclosed in this specification (including any accompanyingclaims abstract and drawings), may be replaced by alternative featuresserving the same, equivalent or similar purpose, unless expressly statedotherwise. Thus, unless expressly stated otherwise, each featuredisclosed is one example only of a generic series of equivalent orsimilar features.

The invention is not restricted to the details of the foregoingembodiment(s). The invention extends to any novel one, or any novelcombination, of the features disclosed in this specication (includingany accompanying claims, abstract and drawings, or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

We claim:
 1. A sacral surface electrode for application of electricalstimulation to patients suffering from incontinence, said sacralelectrode comprising:a conductive material; means, defining a shape ofsaid conductive material, for fitting said sacral electrode to a surfacesacral region of said patients for stimulating nerves in the sacralregion wherein said conductive material has a shape of a generallytruncated triangle and wherein the conductive material includes an apexplateau region and means, defining a dipped portion, for facilitatingfinger placement of the sacral surface electrode over the sacral region;and means for connecting said conductive material to a source ofelectrical stimulation pulses.
 2. Apparatus for application ofelectrical stimulation to patients suffering from incontinence, saidapparatus comprising:generator means for providing a series ofelectrical stimulation pulses; tampon electrode means, responsive tosaid series of electrical stimulation pulses, for causing musclecontraction in order to reduce patient incontinence, said tamponelectrode means comprising an electrically conductive outer sheath andmeans for expanding and contracting the outer sheath to enhanceconduction of the electrical stimulation pulses into a vaginal or analwall of the patient by conforming the outer sheath to the vaginal oranal wall; and sacral surface electrode means, shaped for fitting to asacral region of said patient and responsive to said series ofelectrical stimulation pulses, for stimulating nerves in the sacralregion.
 3. The apparatus according to claim 2 wherein the means forexpanding and contracting the outer sheath comprises means forpneumatically expanding and contracting the outer sheath.